LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K043332
    Device Name
    WHEELCHAIR, MODEL 8500-II
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2004-12-13

    (11 days)

    Product Code
    IOR,89I
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K012370
    Why did this record match?
    Device Name :

    WHEELCHAIR, MODEL 8500-II

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.

    AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.

    AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

    Device Description

    The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

    The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.

    The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

    AI/ML Overview

    The provided text describes a 510(k) summary for the AIDC 8500-II Wheelchair, focusing on its substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a medical AI device.

    Therefore, I cannot fulfill your request for the tables and information outlined in your prompt, as the document is about a manual wheelchair and its non-clinical testing for regulatory approval, not about an AI-powered device or a study examining its performance against acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1